High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis

NCT02954757 | Unknown DMC

• 1 other identifier: UW16-283
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine adenomyosis is a common uterine benign condition. They can cause abnormal menstrual bleeding, and menstrual pain. Although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU) therapy is receiving increasing interest in the management of uterine adenomyosis by inducing focal thermocoagulation of the fibroids. Results obtained by various research groups have shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of uterine adenomyosis. In this proposed study, 10 patients who have symptomatic uterine adenomyosis who meet the study inclusion criteria will be invited to participate in the study which involves the use of HIFU in the management of the adenomyosis. Background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. Subjects will also be asked to complete an eight-item section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) and menstrual pain score which evaluate the effect of the adenomyosis on the quality of life of women.

Conditions

Adenomyosis

Keywords

uterine adenomyosis

Outcome Measures

Primary Outcomes (1)

• Perceived symptoms change after HIFU treatment By using the menstrual pain score

  By using the menstrual pain score for pain evaluation at each follow up (i.e. from baseline to post 1- month, post 1-month to post 3-month, post 3-month to post 6-month, post 6-month to post 12-month treatment will be captured).

  The changes from baseline to post 12-month treatment will be captured

Secondary Outcomes (6)

• Perceived symptoms change after HIFU treatment By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)

  The changes from baseline to post12-month treatment will be captured

• Efficacy of HIFU in reducing the size of the adenomyotic lesion and the uterus by sonographic measurements.

  The changes from baseline to post 12- month treatment will be captured

• Discomfort during procedure by using 10-cm visual analogue scale

  immediate after the treatment

• Patient satisfaction score after HIFU treatment of uterine adenomyosis

  Up to 12 months

• Risks and adverse effects of HIFU in the treatment of adenomyosis

  Up to 12 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

HIFU treatment

Procedure: HIFU treatment

Interventions

HIFU treatment PROCEDURE

High intensity focused ultrasound

Treatment arm

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>40 years old, with no future childbearing plans
• Age \>30 years old, who has tubal sterilization
• Significant symptoms related to adenomyosis, intractable to standard medical therapy, or patient considering radiological intervention (uterine fibroid embolization) or surgery.
• Clinical uterine size less than 20 weeks gestation
• Localized adenomyotic lesion or adenomyoma identified of less than 10 cm in diameter as judged by contrast MRI, involving only anterior or posterior uterine wall and not both.
• No laparotomy scars.
• Women should be able to give consent.

You may not qualify if:

• Other pelvic or uncontrolled systemic diseases
• Confirmed or suspected pregnancy
• Patients who are unable to communicate with researchers during the treatment
• Patients who are contraindicated for MRI examination
• Patients with thick abdominal wall (\>5 cm, as measured by MRI)
• Presence or history of acute pelvic inflammatory disease or any pelvic malignancy
• History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion
• Presence of significant sized fibroids which may interfere with the treatment or affect the outcome measures

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Unknown Facility

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Vincent YT Cheung, MBBS, FRCOG

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: November 3, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

HK (1)